NCT03237351

Brief Summary

Perioperative fluid management is a key component of anesthetic management during thoracic surgery. On one hand, fluid restriction could compromise perfusion of vital organs and surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary complications, notably pulmonary edema, which carries a high mortality rate. Perioperative fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed. Therefore, to achieve the balance between preventing fluid overload and optimising organ perfusion, the practical index to guide fluid management, which can predict whether fluid loading will improve haemodynamic conditions in an individual patient, would be very valuable during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory variations of arterial pressure \[i.e. pulse pressure variation (PPV) and systolic pressure variation\] can predict fluid responsiveness in mechanically ventilated patients under various conditions. Therefore, pressure variations are increasingly being advocated for fluid management.This study will discuss the effects of pulse pressure variation(PPV) in different level during anesthesia on patients with oxygenation index and short-term prognosis undergoing video-assisted thoracoscopic surgery for pneumoresection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2.3 years

First QC Date

July 24, 2017

Last Update Submit

April 21, 2020

Conditions

Goal-directed Fluid Therapy

Keywords

goal-directed fluid therapythoracic surgery, video-assistedacute lung injury

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Oxygenation Index in 48 hours

    Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation

Secondary Outcomes (12)

  • The duration of surgery

    During surgery period

  • The duration of mechanical ventilation

    During surgery period

  • Crystalloid administered

    During surgery period

  • Colloid administered

    During surgery period

  • Blood loss

    During surgery period

  • +7 more secondary outcomes

Study Arms (3)

Conventional therapy group

ACTIVE COMPARATOR

Patients in Conventional therapy group were received fluid therapy: intraoperative transfusion volume=maintenance fluids+deficit replacement+restoration of losses and with heart rate, mean arterial pressure, urine measurement ect.

Device: Fluid therapy

Low value of PPV group

EXPERIMENTAL

Patients in low value of PPV group were received fluid therapy according to PPV (3% ≤PPV \< 5%) .

Device: Fluid therapy

High value of PPV group

EXPERIMENTAL

Patients in high value of PPV group were received fluid therapy according to PPV (5% ≤PPV \< 8%) .

Device: Fluid therapy

Interventions

Fluid therapyDEVICE

Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

Conventional therapy groupHigh value of PPV groupLow value of PPV group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists physical status I-III; aged 18-60 years old; BMI 18.5 \~ 28 kg/m2

You may not qualify if:

  • Refused to participate in the experiment, hepatic/renal/cardiac dysfunction, severe valvular disease, frequent arrhythmia, moderate anemia and severe electrolyte disturbance before operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

Location

Related Publications (6)

  • Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.

    PMID: 19837807BACKGROUND

  • Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.

    PMID: 19602972BACKGROUND

  • Ripolles-Melchor J, Espinosa A, Martinez-Hurtado E, Abad-Gurumeta A, Casans-Frances R, Fernandez-Perez C, Lopez-Timoneda F, Calvo-Vecino JM. Perioperative goal-directed hemodynamic therapy in noncardiac surgery: a systematic review and meta-analysis. J Clin Anesth. 2016 Feb;28:105-15. doi: 10.1016/j.jclinane.2015.08.004. Epub 2015 Oct 2.

    PMID: 26440438BACKGROUND

  • Chau EH, Slinger P. Perioperative fluid management for pulmonary resection surgery and esophagectomy. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):36-44. doi: 10.1177/1089253213491014. Epub 2013 May 29.

    PMID: 23719773BACKGROUND

  • Zhang J, Chen CQ, Lei XZ, Feng ZY, Zhu SM. Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thoracoscopy lobectomy operations: a pilot study. Clinics (Sao Paulo). 2013 Jul;68(7):1065-70. doi: 10.6061/clinics/2013(07)27.

    PMID: 23917675BACKGROUND

  • Lee JH, Jeon Y, Bahk JH, Gil NS, Hong DM, Kim JH, Kim HJ. Pulse pressure variation as a predictor of fluid responsiveness during one-lung ventilation for lung surgery using thoracotomy: randomised controlled study. Eur J Anaesthesiol. 2011 Jan;28(1):39-44. doi: 10.1097/EJA.0b013e32834089cf.

    PMID: 21088596BACKGROUND

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair of Department of Anesthesiology

Study Record Dates

First Submitted

July 24, 2017

First Posted

August 2, 2017

Study Start

September 1, 2017

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)